Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical
company developing and delivering novel therapies for the
management of central nervous system (CNS) disorders, today
reported financial results for the fourth quarter and full year
ended December 31, 2022.
“The past year was a landmark for Axsome, which
saw us bring our first fully in-house end-to-end developed drug to
market, potentially transforming the treatment landscape for
depression and providing the potential to improve the lives of
millions of patients and their loved ones,” said Herriot Tabuteau,
MD, Chief Executive Officer of Axsome. “With two differentiated
products in Auvelity and Sunosi now commercialized, encouraging
early launch metrics for Auvelity, a broad and advancing late-stage
CNS pipeline, and a strong financial position, Axsome is well
positioned to continue to deliver significant value to patients and
shareholders. We are looking forward to another milestone filled
year which has already kicked off with an important licensing
agreement for Sunosi in Europe that serves to expand patient access
to this important treatment while providing significant potential
future value to Axsome. Over the next 12 to 18 months, we look to
continuing to execute on the commercialization of Auvelity and
Sunosi, initiating or reading out at least four registration trials
in indications of high unmet need, and potentially filing four new
NDAs.”
Fourth Quarter 2022 Financial
Highlights
- Total
net sales were $24.4 million and $50.0 million for the fourth
quarter and full year of 2022 respectively, compared to none for
the 2021 comparable periods. Auvelity was launched on October 19,
2022 and had U.S. net sales of $5.2 million for the fourth quarter
of 2022. No Auvelity sales were reported by Axsome for the 2021
comparable period reflecting the timing of the Auvelity approval
and launch. Net sales of Sunosi to Axsome were $19.2 million and
$44.8 million for the fourth quarter and full year of 2022
respectively. Axsome began selling Sunosi in the U.S. in May 2022
and in certain international markets in November 2022. Therefore no
Sunosi sales were reported by Axsome for the 2021 comparable
periods.
- Total
cost of product sales were $2.3 million and $5.2 million for the
fourth quarter and full year of 2022 respectively, compared to none
for the 2021 comparable periods.
- Research
and development (R&D) expenses were $14.7 million and $57.9
million for the fourth quarter and full year of 2022 respectively,
compared to $13.8 million and $58.1 million for the comparable
periods in 2021, respectively. The increase for the fourth quarter
was primarily related to higher costs associated with ongoing
clinical trials, including post-marketing commitments for Sunosi
and Auvelity.
- Selling,
general, and administrative (SG&A) expenses were $61.5 million
and $159.3 million for the fourth quarter and full year of 2022
respectively, compared to $18.8 million and $66.6 million for the
comparable periods in 2021, respectively. The increases were
primarily related to commercial activities for Sunosi and Auvelity,
including sales force onboarding, marketing spend, and higher
non-cash stock compensation expense.
- Net loss was
$61.2 million, or $(1.41) per share, for the fourth quarter of
2022, compared to a net loss of $34.0 million, or $(0.90) per
share, for the comparable period in 2021. The net loss for the
fourth quarter of 2022 included $10.8 million of non-cash stock
compensation expense compared to $5.9 million in the comparable
period in 2021. Net loss was $187.1 million, or $(4.60) per share,
for the full year of 2022, compared to a net loss of $130.4
million, or $(3.47) per share, for the full year of 2021. The net
loss for the full year 2022 included $37.7 million of non-cash
stock compensation expense compared to $20.8 million for the full
year 2021.
- Cash and cash
equivalents totaled $200.8 million at December 31, 2022, compared
to $86.5 million at December 31, 2021. In January 2023, Axsome
amended its loan agreement with Hercules Capital increasing the
size of the facility to $350 million, reducing the interest rate,
and extending the maturity and interest-only period, while
accessing a new $55 million tranche. In addition, In February 2023
the Company received approximately $66 million from the
out-licensing of ex-U.S. rights to Sunosi. Inclusive of these
events, the pro forma December 31, 2022 cash balance is in excess
of $300 million.
- Shares of
common stock outstanding were 43,498,617 at December 31, 2022.
Financial Guidance
- Axsome believes
that its current cash, along with the remaining committed capital
from the $350 million term loan facility, is sufficient to fund
anticipated operations into cash flow positivity, based on the
current operating plan, which includes the continued
commercialization of Sunosi and Auvelity.
- Axsome expects
that its operating expenses will increase year over year as the
Company commercializes Sunosi and Auvelity and continues to advance
its pipeline.
Commercial Highlights
Auvelity
- Axsome
commercially launched Auvelity on October 19, 2022. Early
prescription trends reflect strong adoption from prescribers and
patients.
-
Effective January 2023, Axsome has contracted with one of the
largest group purchasing organizations (GPO) for potential
formulary coverage of Auvelity. Pharmacy benefit managers and
health plans under this GPO are now able to make coverage decisions
for Auvelity based on the contracted terms. Medicaid coverage
became effective in all states except Texas on January 1, and
Medicare coverage is expected to become available approximately 6
months post launch.
-
Axsome’s comprehensive patient and provider support services
continue to perform as planned. The Auvelity on My Side program is
designed to help clinicians and patients easily access Auvelity and
the program includes: the Auvelity Savings Card to reduce
out-of-pocket expenses for qualifying patients, telehealth
services, HCP samples, and prior authorization assistance.
Sunosi
- U.S.
Sunosi performance in the fourth quarter reflects continued focus
on commercial execution. Fourth quarter U.S. Sunosi total
prescriptions increased by 11% versus the fourth quarter of 2021,
and by 1% versus the third quarter of 2022. Full year Sunosi total
prescriptions grew 21% in 2022 vs. 2021.
- Sunosi
has broad payer coverage in the commercial channel with 96% of
lives covered. Currently 83% of total lives are covered.
- In the
fourth quarter of 2022, Axsome closed the ex-U.S. acquisition of
Sunosi. Subsequently in February 2023, Axsome licensed the
marketing rights for Sunosi in Europe and certain countries in the
Middle East and North Africa (MENA) to Pharmanovia. In
consideration, Axsome received an upfront payment of $66M, with
potential milestones up to $101M. Axsome will receive a royalty
percentage in the mid-twenties on net sales in the licensed
territory. Pharmanovia will assume responsibility for all local
clinical and regulatory activities and requirements including
studies in pediatric patients with narcolepsy.
Development Pipeline
Axsome is advancing a portfolio of
differentiated, patent-protected, CNS product candidates with five
in active clinical development. Recent and anticipated progress for
key pipeline programs is summarized below.
AXS-05
AXS-05 (dextromethorphan-bupropion) is Axsome’s
novel, oral, investigational NMDA receptor antagonist with
multimodal activity being developed for Alzheimer’s disease (AD)
agitation and smoking cessation. AXS-05 has been granted U.S. Food
and Drug Administration (FDA) Breakthrough Therapy designation for
AD agitation.
-
Alzheimer’s Disease Agitation: In November 2022,
Axsome announced positive topline results from the ACCORD trial, a
Phase 3, placebo-controlled, randomized withdrawal trial of AXS-05
in patients with AD agitation. The study met its primary and key
secondary endpoints by substantially and statistically
significantly delaying the time to relapse and preventing relapse
of agitation symptoms as compared to placebo.The Company is
conducting the ADVANCE-2 study, a Phase 3, placebo-controlled,
parallel group trial to assess the efficacy and safety of AXS-05
for the treatment of AD agitation. Patients completing ADVANCE-2
may enter a long-term open label safety extension trial. Based on
current enrollment trends, the Company now anticipates completion
of ADVANCE-2 in the first half of 2024, versus prior guidance of
mid-2025.Axsome recently received feedback from the FDA on the
clinical development program of AXS-05 in AD agitation. The FDA
feedback indicated that an NDA for AXS-05 in this indication should
include placebo-controlled safety information from the ongoing
ADVANCE-2 trial, as well as long-term safety data in the target
patient population consisting of at least 300 patients treated for
six months and 100 patients treated for one year. Based on this
guidance, the Company intends to submit an NDA for AXS-05 after
completion of the ongoing ADVANCE-2 and open-label safety extension
trials.
-
Smoking Cessation: Axsome plans to proceed to a
pivotal Phase 2/3 trial in this indication. The Company anticipates
initiation of this study in the fourth quarter of 2023.
AXS-07
AXS-07 (MoSEIC™ meloxicam-rizatriptan) is
Axsome’s novel, oral, rapidly absorbed, multi-mechanistic,
investigational medicine for the acute treatment of migraine.
-
Migraine: Manufacturing activities related to the
planned resubmission of the New Drug Application (NDA) for AXS-07
for the acute treatment of migraine are ongoing. The Company
anticipates resubmission of the NDA in the second half of 2023. No
additional clinical efficacy or safety trials have been requested
by the FDA for a resubmission of the NDA. The Company expects the
NDA resubmission to be designated as Class 2 which would be subject
to a six-month review.
AXS-12
AXS-12 (reboxetine) is Axsome’s novel, oral,
potent, investigational highly selective norepinephrine reuptake
inhibitor for the treatment of narcolepsy. AXS-12 has been granted
FDA Orphan Drug designation for the treatment of narcolepsy.
-
Narcolepsy: Axsome is conducting the SYMPHONY
study, a Phase 3 randomized, multicenter, double-blind,
placebo-controlled, parallel-group trial of AXS-12 in the treatment
of narcolepsy. Enrollment in the trial is progressing and topline
results continue to be anticipated in the first half of 2023.
AXS-14
AXS-14 (esreboxetine) is Axsome’s novel, oral,
potent, investigational highly selective norepinephrine reuptake
inhibitor for the management of fibromyalgia. Esreboxetine, the
SS-enantiomer of reboxetine, is more potent and selective than
racemic reboxetine.
-
Fibromyalgia: Manufacturing and other activities
related to the planned submission of an NDA for AXS-14 for the
management of fibromyalgia are ongoing. The Company expects to
submit the NDA in 2023. AXS-14 has previously met the primary
endpoints and demonstrated positive and statistically significant
results in a Phase 3 and in a Phase 2 trial for the management
of fibromyalgia.
Solriamfetol
Solriamfetol is Axsome’s dual-acting dopamine
and norepinephrine reuptake inhibitor in development for the
treatment of attention deficit hyperactivity disorder (ADHD).
-
ADHD: The Company is preparing to initiate a Phase
3 multi-center, randomized, double-blind, placebo-controlled trial
to evaluate the efficacy and safety of solriamfetol in adults with
ADHD in the first half of 2023.
-
Cognitive function: In October, the Company
announced that solriamfetol met the primary endpoint in the SHARP
study and significantly improved cognitive function, as measured by
the DSST RBANS, in cognitively impaired patients with excessive
daytime sleepiness associated with obstructive sleep apnea,
compared to placebo (p=0.009). Superiority of solriamfetol as
compared to placebo was further demonstrated using patient-reported
measures of cognitive function.
Anticipated Milestones
-
Regulatory and Commercial:
- AXS-07
for migraine, NDA resubmission (2H 2023)
- AXS-14
for fibromyalgia, NDA submission (2023)
-
Clinical Trial Readouts:
- Phase 3
SYMPHONY trial of AXS-12 in narcolepsy, topline data (1H 2023)
- Phase 3
ADVANCE-2 trial of AXS-05 for Alzheimer’s disease agitation (1H
2024)
-
Clinical Trial Initiations:
- Phase 3
trial of solriamfetol for ADHD in adults (1H 2023)
- Pivotal
Phase 2/3 trial of AXS-05 for smoking cessation (4Q 2023)
Conference Call Information
Axsome will host a conference call and webcast
today at 8:00 AM Eastern to discuss fourth quarter 2022 financial
results as well as to provide a corporate update. To participate in
the live conference call, please dial (877) 405-1239 (toll-free
domestic). The live webcast can be accessed on the "Webcasts &
Presentations" page of the "Investors" section of the Company’s
website at axsome.com. A replay of the webcast will be available
for approximately 30 days following the live event.
About Axsome Therapeutics,
Inc.
Axsome Therapeutics, Inc. is a biopharmaceutical
company developing and delivering novel therapies for central
nervous system (CNS) conditions that have limited treatment
options. Through development of therapeutic options with novel
mechanisms of action, we are transforming the approach to treating
CNS conditions. At Axsome, we are committed to developing products
that meaningfully improve the lives of patients and provide new
therapeutic options for physicians. For more information, please
visit the Company’s website at axsome.com. The Company may
occasionally disseminate material, nonpublic information on the
company website.
Forward Looking Statements
Certain matters discussed in this press release
are "forward-looking statements". We may, in some cases, use terms
such as "predicts," "believes," "potential," "continue,"
"estimates," "anticipates," "expects," "plans," "intends," "may,"
"could," "might," "will," "should" or other words that convey
uncertainty of future events or outcomes to identify these
forward-looking statements. In particular, the Company's statements
regarding trends and potential future results are examples of such
forward-looking statements. The forward-looking statements include
risks and uncertainties, including, but not limited to, the
continued commercial success of our Sunosi® and Auvelity® products
and the success of our efforts to obtain any additional
indication(s) with respect to solriamfetol and/or AXS-05; the
success, timing and cost of our ongoing clinical trials and
anticipated clinical trials for our current product candidates,
including statements regarding the timing of initiation, pace of
enrollment and completion of the trials (including our ability to
fully fund our disclosed clinical trials, which assumes no material
changes to our currently projected expenses), futility analyses and
receipt of interim results, which are not necessarily indicative of
the final results of our ongoing clinical trials, and the number or
type of studies or nature of results necessary to support the
filing of a new drug application ("NDA") for any of our current
product candidates; our ability to fund additional clinical trials
to continue the advancement of our product candidates; the timing
of and our ability to obtain and maintain U.S. Food and Drug
Administration ("FDA") or other regulatory authority approval of,
or other action with respect to, our product candidates; whether
issues identified by FDA in the complete response letter may impact
the potential approvability of the Company's NDA for AXS-07 for the
acute treatment of migraine in adults with or without aura,
pursuant to our special protocol assessment for the MOMENTUM
clinical trial; the Company's ability to successfully defend its
intellectual property or obtain the necessary licenses at a cost
acceptable to the Company, if at all; the successful implementation
of the Company's research and development programs and
collaborations; the success of the Company's license agreements;
the acceptance by the market of the Company's products and product
candidates, if approved; the Company's anticipated capital
requirements, including the amount of capital required for the
continued commercialization of Sunosi and Auvelity and for the
Company's commercial launch of its other product candidates, and
the potential impact on the Company's anticipated cash runway;
unforeseen circumstances or other disruptions to normal business
operations arising from or related to COVID-19; and other factors,
including general economic conditions and regulatory developments,
not within the Company's control. The factors discussed herein
could cause actual results and developments to be materially
different from those expressed in or implied by such statements.
The forward-looking statements are made only as of the date of this
press release and the Company undertakes no obligation to publicly
update such forward-looking statements to reflect subsequent events
or circumstance.
Axsome Therapeutics,
Inc.Selected Consolidated Financial
Data
Axsome Therapeutics,
Inc.Consolidated Balance Sheets
|
|
December 31, |
|
|
December 31, |
|
|
2022 |
|
|
2021 |
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
200,841,955 |
|
|
$ |
86,472,854 |
|
Accounts receivables, net |
|
|
37,698,868 |
|
|
|
— |
|
Inventories, net |
|
|
4,319,921 |
|
|
|
— |
|
Prepaid and other current assets |
|
|
2,780,665 |
|
|
|
45,286 |
|
Total current assets |
|
|
245,641,409 |
|
|
|
86,518,140 |
|
Equipment, net |
|
|
722,515 |
|
|
|
283,846 |
|
Right-of-use asset - operating
lease |
|
|
420,298 |
|
|
|
660,162 |
|
Goodwill |
|
|
10,310,000 |
|
|
|
— |
|
Intangible asset, net |
|
|
59,660,772 |
|
|
|
— |
|
Non-current inventory and other
assets |
|
|
14,721,101 |
|
|
|
322,910 |
|
Total assets |
|
$ |
331,476,095 |
|
|
$ |
87,785,058 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
38,605,312 |
|
|
$ |
13,149,329 |
|
Accrued expenses and other current liabilities |
|
|
51,630,813 |
|
|
|
9,295,180 |
|
Operating lease liability, current portion |
|
|
424,673 |
|
|
|
620,675 |
|
Contingent consideration, current |
|
|
5,900,000 |
|
|
|
— |
|
Total current liabilities |
|
|
96,560,798 |
|
|
|
23,065,184 |
|
Contingent consideration,
non-current |
|
|
31,100,000 |
|
|
|
— |
|
Loan payable, long-term |
|
|
94,258,888 |
|
|
|
49,089,522 |
|
Total liabilities |
|
|
221,919,686 |
|
|
|
72,154,706 |
|
Stockholders’ equity: |
|
|
|
|
|
|
Preferred stock, $0.0001 par
value per share (10,000,000 shares authorized, none issued and
outstanding at December 31, 2022 and December 31, 2021,
respectively) |
|
|
— |
|
|
|
— |
|
Common stock, $0.0001 par value
per share (150,000,000 shares authorized, 43,498,617 and 37,816,794
shares issued and outstanding at December 31, 2022 and December 31,
2021, respectively) |
|
|
4,350 |
|
|
|
3,782 |
|
Additional paid-in capital |
|
|
705,884,795 |
|
|
|
424,825,655 |
|
Accumulated deficit |
|
|
(596,332,736 |
) |
|
|
(409,199,085 |
) |
Total stockholders’ equity |
|
|
109,556,409 |
|
|
|
15,630,352 |
|
Total liabilities and
stockholders’ equity |
|
$ |
331,476,095 |
|
|
$ |
87,785,058 |
|
|
|
|
|
|
|
|
|
|
Axsome Therapeutics,
Inc.Consolidated Statements of
Operations
|
Three Months Ended |
|
Twelve Months Ended |
|
December 31, |
|
December 31, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
Product sales, net |
$ |
24,371,528 |
|
|
$ |
- |
|
|
$ |
50,037,106 |
|
|
$ |
- |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Cost of product sales
(excluding amortization and depreciation) |
|
2,290,928 |
|
|
|
- |
|
|
|
5,197,595 |
|
|
|
- |
|
Research and development |
|
14,693,083 |
|
|
|
13,781,453 |
|
|
|
57,947,447 |
|
|
|
58,060,725 |
|
Selling, general and administrative |
|
61,497,347 |
|
|
|
18,826,588 |
|
|
|
159,253,661 |
|
|
|
66,646,205 |
|
Loss in fair value of contingent consideration |
|
4,200,350 |
|
|
|
- |
|
|
|
3,298,230 |
|
|
|
- |
|
Intangible asset amortization |
|
1,606,789 |
|
|
|
- |
|
|
|
4,139,228 |
|
|
|
- |
|
Total operating expenses |
|
84,288,497 |
|
|
|
32,608,041 |
|
|
|
229,836,161 |
|
|
|
124,706,930 |
|
Loss from operations |
|
(59,916,969 |
) |
|
|
(32,608,041 |
) |
|
|
(179,799,055 |
) |
|
|
(124,706,930 |
) |
Interest expense, net |
|
(1,322,643 |
) |
|
|
(1,368,095 |
) |
|
|
(7,334,596 |
) |
|
|
(5,696,062 |
) |
Net loss |
$ |
(61,239,612 |
) |
|
$ |
(33,976,136 |
) |
|
$ |
(187,133,651 |
) |
|
$ |
(130,402,992 |
) |
Net loss per common share,
basic and diluted |
$ |
(1.41 |
) |
|
$ |
(0.90 |
) |
|
$ |
(4.60 |
) |
|
$ |
(3.47 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
43,447,309 |
|
|
|
37,764,545 |
|
|
|
40,665,941 |
|
|
|
37,618,599 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Axsome Contacts:Investors:Mark JacobsonChief
Operating OfficerAxsome Therapeutics, Inc.22 Cortlandt Street, 16th
FloorNew York, NY 10007Tel: 212-332-3243Email: mjacobson@axsome.com
www.axsome.com
Media:Darren OplandDirector, Corporate
CommunicationsAxsome Therapeutics, Inc.22 Cortlandt Street, 16th
FloorNew York, NY 10007Tel: 929-837-1065Email: dopland@axsome.com
www.axsome.com
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